1、Study protocolStudy protocolCriteriaStudy protocol articles will generally only be considered for proposed or ongoing trials that have not completed participant recruitment at the time of submission.Trialsadvises that study protocols are submitted well before recruitment completes, however we will a
2、lso on occasion consider study protocols submitted before the last patient/last visit. This, including an explanation of why it was not possible to submit earlier, should be included within the manuscript text. Please confirm the status of your study at submission.Please note:From 1st January 2021,T
3、rialswill no longer consider study protocols for pilot or feasibility trials for publication. We recommend that these manuscripts are instead submitted to our sister journal,Pilot and Feasibility Studies.Trialsalso considers study protocols assessing aspects of the design, conduct or reporting of ra
4、ndomized trials. These studies do not necessarily need to be trials and include studies such as core outcome set development for use in trials and process evaluations that run alongside trials. Please follow therelevant reporting guidelinefor the study design and include the corresponding checklist
5、as an additional file. The online protocol template calledSEPTRE (SPIRIT Electronic Protocol Tool & Resource)is a web-based option to create, manage, and register protocols using the SPIRIT guidance.All submitted protocols must have ethical approval. If the study has undergone full external peer rev
6、iew as part of the funding process, the study protocol will usually only undergo editorial peer review by a Protocol Editor. Study protocols without major external funding will undergo full, external peer review. Study protocols without ethical approval will generally not be considered. To support e
7、fficient handling of your study protocol, the Editors advise that prospective authors familiarize themselves with thisEditorial on what is expected in a study protocol submission.Additional FilesOn submission, the following documentation should be uploaded as Additional Files. If the original docume
8、nts are not in English, an English translation of each is mandatory.Ethical approval documentCopy of the original funding documentationA completed SPIRIT checklist (unless thestructured study protocol templatehas been used), or checklist for another appropriate reporting guidelineSPIRIT GuidanceStud
9、y protocols reporting a clinical trial can be formatted for submission toTrialsin two ways:1.By following the guidance set out in ourstructured study protocol template. This is the preferred option if you have not yet started writing your manuscript.2.By submitting a populated SPIRIT checklist (i.e.
10、 page and line numbers next to each item corresponding to where it is found within the protocol) and SPIRIT figure alongside your manuscript. The SPIRIT 2013 Statement, 33-item checklist and figure can be downloadedhere. The figure should be included in the main body of the text and the checklist sh
11、ould be provided as anadditional file, both the figure and the checklist should be referenced in the text. Submissions received without these elements will be returned to the authors as incomplete.It is understood that for some study protocols certain aspects may not comply fully with each item of t
12、he SPIRIT Statement. If used, the checklist will not be used as a tool for judging the suitability of manuscripts for publication inTrials, but is intended as an aid for authors to clearly, completely, and transparently let reviewers and readers know what authors intend to do. Where an item is not a
13、pplicable, authors can state this but must also add a brief explanation as to why the item is not applicable. Eg.Biological Specimens, Item no. 33: Not applicable, no samples collected.Simply saying N/A will lead to the manuscript being returned. A completed SPIRIT checklist should look likethis. Li
14、kewise, if the structured protocol template is used, please follow the guidance by leaving all headings, identifiers and curly brackets in the order given and provide a complete response under each. A complete example can be foundhere.In ReviewAuthors submitting to Trials can now opt-in to a service
15、 calledIn Review, which provides a pre-print service, meaning the article can be shared with funders and others in a citeable way while it is under review. It also provides authors with on-demand information on the status of their manuscript, enables them to share their work with funders and others,
16、 and allows their wider community to comment and collaborate - all whilst their manuscript is under review. Please seehere for full details.Preparing your manuscriptThe information below details the section headings that you should include in your manuscript and what information should be within eac
17、h section.Please note that your manuscript must include a Declarations section including all of the subheadings (please see below for more information).Title pageThe title page should:present a title including information about the study design, population, interventions, and, if applicable, trial a
18、cronym, using the following format “_: study protocol for a _trial.”list the full names, institutional addresses and email addresses for all authorsoif a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members
19、of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions belowindicate the corresponding authorAbstractThe Abstract should not exceed 350 words. Please minimize the use of abbreviation
20、s and do not cite references in the abstract. The abstract must include the following separate sections:Background:the context and purpose of the studyMethods:how the study will be performedDiscussion:a brief summary and potential implicationsTrial registration:If your article reports the results of
21、 a health care intervention on human participants, it must be registered in aWHO ICRTP registry. The name of the registry, registration number and date of registration should all be stated in this section. If it was not registered prospectively (before enrollment of the first participant), you shoul
22、d include the words retrospectively registered. See our editorial policies for more information on trial registration.KeywordsThree to ten keywords representing the main content of the article.BackgroundThe Background section should explain the background to the study, its aims, a summary of the exi
23、sting literature and why this study is necessary or its contribution to the field.Methods/DesignThe methods section should include:the aim, design and setting of the studythe characteristics of participants or description of materialsa clear description of all processes, interventions, comparisons a
24、nd details of the randomization process. Generic drug names should generally be used. When proprietary brands are used in research, include the brand names in parenthesesthe type of statistical analysis used, including a power calculation if appropriate.DiscussionThis should include a discussion of
25、any practical or operational issues involved in performing the study and any issues not covered in other sections.Trial statusAuthors should report the protocol version number and date, the date recruitment began, and the approximate date when recruitment will be completed.List of abbreviationsIf ab
26、breviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided. Please try not to include too many unnecessary acronyms and abbreviations within the text. If this hinders the legibility of the manuscript, you may be asked to remove th
27、ese by the Editor.DeclarationsAll manuscriptsmustcontain the following sections under the heading Declarations:Ethics approval and consent to participateConsent for publicationAvailability of data and materialsCompeting interestsFundingAuthors contributionsAcknowledgementsAuthors information (option
28、al)Please see below for details on the information to be included in these sections. If any of the sections are not relevant to your manuscript, please include the heading and write Not applicable for that section.Ethics approval and consent to participateTrialsdo not consider study protocols for st
29、udies without ethical approval. You will be required to provide a copy of the original ethical approval document and an English translation of this document as an additional file on submission, which will be checked against this declaration. The name of the ethics committee that approved the study a
30、nd the committees reference number (if applicable) should be declared. Details of authors intentions to obtain consent to participate in the study from participants (or their parent or legal guardian in the case of children under 16) should be declared. “eg.ABC Ethical Review Board ABC123456. Writte
31、n, informed consent to participate will be obtained from all participants”More informationConsent for publicationPlease do not include any baseline or pilot data in your study protocol. The Editorial Office will ask you to remove this if it is included. If you have included any details, images or vi
32、deos relating to an individual person, written informed consent for the publication of these details must be obtained from that person (or their parent or legal guardian in the case of children under 18) and declared in this section. Please also state whether you will be willing to provide a model consent form on request. If this section does not apply, please state “Not applicable”.More informationAvailability of data and materialsPlease do not include
